Thursday, April 09, 2020

California Stem Cell Agency Set to Finance Anti-Covid-19 Plasma Research

In a rare move, California's stem cell agency is set to expand beyond its traditional scope and finance research involving the use of blood plasma for treatment of Covid-19 patients. 

It would be only the second time that the agency, known formally as the California Institute for Regenerative Medicine (CIRM), has invoked the "vital research opportunity" clause in the 10,000-word ballot initiative that created the agency in 2004. 

Under the initiative, CIRM is restricted to using its $3 billion for stem cell research -- not the vast array of possibilities for the entire field of biomedical research. But a little-noticed provision also allowed for exceptions in the case of "vital research opportunities."  

The proposed action tomorrow would include plasma research in a new, $5 million effort approved two weeks ago to support stem cell research involving Covid-19. On Tuesday, the agency received 19 applications for funding under that fresh, ongoing effort. Another deadline for applications is expected in about two weeks. 

The expansion to include plasma will be presented to the CIRM governing board tomorrow at 11 a.m. PDT during a public, online meeting. It includes funding "proposals to study convalescent plasma or its derivatives (e.g., immunoglobulin) for the treatment of patients with COVID-19."

The plan also said,
"Clinical studies of convalescent plasma may propose use of the FDA’s single-patient emergency IND (eIND investigational new drug) pathway to satisfy the (agency's) CLIN2 eligibility requirements for a traditional IND."
CIRM's $5 million coronavirus effort might seem skimpy to those used to thinking of the agency as a $3 billion program. It was a $3 billion effort 15 years ago. Today the agency is running out of cash and is down to its last $27 million, which is largely committed to a sickle cell round. 

CIRM is hoping that a proposed, $5.5 billion ballot initiative will qualify for the November ballot, be approved by voters and give it at least another 10 years of life.  

The first occasion for invoking the "vital research" clause involved gene therapies. 

The public can listen in on tomorrow's meeting and make comments. Instructions for online access can be found on the meeting agenda. 

Here is a look at a national plasma effort already underway. Here are federal recommendations concerning such research. 

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